RAFASSAL 1 GRAM ENEMA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MESALAZINE

Available from:

RAFA LABORATORIES LTD

ATC code:

A07EC02

Pharmaceutical form:

ENEMA

Composition:

MESALAZINE 1 G

Administration route:

RECTAL

Prescription type:

Required

Manufactured by:

RAFA LABORATORIES LTD, JERUSALEM

Therapeutic group:

MESALAZINE

Therapeutic area:

MESALAZINE

Therapeutic indications:

Treatment and prevention of ulcerative colitis and Crohn's disease.

Authorization date:

2022-11-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
1986
-
REGULATIONS (PREPARATIONS)
The medicine is dispensed with a doctor’s prescription only
Rafassal
®
1 gram Enema
Rafassal
®
4 gram Enema
Active ingredient:
Each Rafassal 1 gram Enema contains: mesalazine 1 gram.
Each Rafassal 4 gram Enema contains: mesalazine 4 gram.
The active ingredient is also called mesalamine or 5-aminosalicylic
acid.
For the list of the additional ingredients, see section 6. See also
‘Important information about
some of the medicine’s ingredients’ in section 2.
Read the entire leaflet carefully before using the medicine.
This leaflet contains concise information about the medicine. If you
have any further questions,
please refer to the doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1. What is the medicine intended for?
The medicine is intended for treatment and prevention of ulcerative
colitis (ulcerative
inflammation of the large intestine) and Crohn's disease.
Therapeutic group: anti-inflammatory medicine from the salicylate
group.
2. Before using the medicine
Do not use the medicine if:
•
You are sensitive (allergic) to the active ingredient, to salicylic
acid, to salicylates such as
acetylsalicylic acid (aspirin) or to any of the additional ingredients
the medicine contains (for the
list of the additional ingredients, see section 6).
•
You suffer from severe impairment of liver or kidney function.
Special warnings regarding the use of the medicine:
Before (and during) treatment with the medicine, tell your doctor if:
•
You suffer or have suffered in the past from lung problems,
particularly if you suffer from asthma
(bronchial).
•
You suffer or have suffered in the past from allergy to a substance
named sulphasalazine, which
is a substance related to the active ingredient mesalazine. In such a
case, close medical
supervision will be required. (If acute symptoms of

Summary of Product characteristics

1
Rafassal Enema-DL-July 2023-04
1
NAME OF THE MEDICINAL PRODUCT
RAFASSAL
®
1 GRAM ENEMA.
RAFASSAL
®
4 GRAM ENEMA
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RAFASSAL 1 GRAM ENEMA: Each enema contains mesalazine
(5-aminosalicylic acid) 1 gram.
RAFASSAL 4 GRAM ENEMA: Each enema contains mesalazine
(5-aminosalicylic acid) 4 gram.
Each enema contains 60 gram suspension.
Excipients with known effect:
Rafassal Enemas contain potassium metabisulphite (281 mg per bottle).
Rafassal Enemas contain sodium benzoate (60 mg per bottle).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Enema for rectal use.
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment and prevention of ulcerative colitis and Crohn's disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology (oral and rectal)
During the acute inflammatory stage and in long-term maintenance
therapy, Rafassal must be taken reliably
and consistently by the patient. This is essential in order to attain
the desired therapeutic success.
_Rafassal Caplets _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
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_ _
For acute inflammatory symptoms:
Individual dosage up to 4 gram/day, divided into 2 or 3 doses.
Rafassal Caplets should be taken with an ample amount of fluid 1 hour
before meals.
As soon as remission occurs, the dose should be reduced (to 2 g
divided into 2 or 3 doses, to avoid
recurrence.
Children_ _
There is only limited documentation for an effect in children (age
6-18 years).
Children 6 years of age and older
ACTIVE DISEASE: To be determined individually, starting with 30-50
mg/kg/day in divided doses. Maximum
dose: 75 mg/kg/day. The total dose should not exceed the maximum adult
dose (4 grams).
2
MAINTENANCE TREATMENT (ULCERATIVE COLITIS): To be determined
individually, starting with
15-30 mg/kg/day in divided doses. The total dose should not exceed the
recommended adult dose (2 grams).
It is generally recommended that half the adult dose may be given to
children up to a body weight of 40
kg; and the normal adult dose to those above 40 kg.
_Rafass